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Anthrax Vaccine Countermeasures
Biomedical Ad anced Research and De elopment A thorit (BARDA)Biomedical Advanced Research and Development Authority (BARDA)
Tom Dreier, PhDTom Dreier, PhDSubject Matter Expert
HHS/ASPR/BARDA
Outline
• The Threat• RequiR irements• Current Program
─ Near term─ Near term─ Mid term─ Long term
• Technical Issue of BAA• Working with BARDA
1
Bacillus anthracis the Threat
• General─ Gram positive spore
forming bacterium─ Resulting disease –Resulting disease
Anthrax─ Naturally occurring
zoonoti ditic disease
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rax
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• ID50 – 3000 spores• 1-6 day incubation period• Non-contagious• Highly stable• Easily mass produced
Anthrax Vaccines Program Alignment with Overall CBRN Strategiesg
• BARDA is building a balanced and diversified portfolio of anthrax countermeasuresof anthrax countermeasures─ Antibiotics─ Antitoxins
V i─ Vaccines
• HHS Requirement to procure sufficient vaccine to protect 25M people
• Programs are supported by:─ Advanced Research and Development─ Project BioShield Special Reserve Fund
3
Anthrax VaccinesCurrent and Near Term PreparednessCurrent and Near Term Preparedness
• Procurement of BioThrax® (AVA) has transitioned to the SNSthe SNS
• Obtain extended expiry dating • Label claim for PEPLabel claim for •
PEPEvaluating Public Health Preparedness
4
Public Health Preparedness
g
er ss
5
• EvalE luatition of df doseand antigen sparin
• c eS h dul• S h d le• Pediatrics and oth
special populationspecial population
Anthrax Vaccine Adjuvant and Stabilization - Mid TermStabilization Mid Term
•Potential to P i dl decrease antigen and/or dose•E d t k ilExpands stockpile
6
Expanded Manufacturing – Mid Term
• Builds on AVA database• Facility Validation• Increases capacityp y to from 8 M to 26M doses/yr
7
rPA Based LongTerm
capabili i•Broadens manufacturing
bilities
•Reduces reliance on one product/manufacturer
8
Novel Technologies – Long Term
• Maintains pipeline of MCMs for future platforms
• Better delivery syy ystems• Supported by the NIH Tech Base
9
Working with BARDAAdvanced Development—CBRN BAAAdvanced Development CBRN BAA
• Opportunities to address anthrax vaccine needs within the CBRN BAAwithin the CBRN BAA─ Area 1: Vaccines and vaccine enhancements
• Impprovements to current vaccines and other vaccine candidates at TRL-6 and above (pending availability of funds)
• Interested in new apppproaches• Organizations should:
─ Demonstrate immunogenicity in one animal─ Understand the manufacturing process at small scaleUnderstand the manufacturing process at small scale─ Determined one year stability─ Define appropriate assay for potency, stability, and
manufacturingg
10
Anthrax Vaccine Successes
• PEP animal model• New rPAN PA vacciine contracts• In conjunction with NIH several contract evaluating
adjuvant and stability enhancing capabilitiesadjuvant and stability enhancing •
capabilitiesUnder the platform BAA – evaluating another rPA expression platform
• BARDA resources available to support contractors
11
Working with BARDA
• BARDA awards contracts─ Generally one year base with option years─ Milestones─ Deliverables
• Project Coordination Team (PCT)─ Each contract has a unique BARDA PCT─ Structure (matrix organized)
• Contracting• Contracting Officer (CO)Officer (CO)• Project Officer (PO)• Manufacturing SME• Animal Model SME• Assay SME• Quality• Earned Value Management
12
PCT Objectives
• PCT provide recommendation to the CO related to the contractcontract─ Only the CO can change the contract (should be done in
writing)• PCT provides technical information up the chain of
commandAssessment─ Assessment project statusproject status
─ Justification for funding─ Coordination of intra-agencyg y concerns
• Intent of PCT is to leverage what has been learned
13
Interaction with PCT for Success
• Plan aheadM t mall j j─ Map out a tll jor projects
─ Be realistic• CommunicationsCommunications
─ Provide honest and timely information─ Inform BARDA of problems─ Support path forward with data─ Oral presentations should be supported by a written report
Scheduled meetings should include the key─ Scheduled meetings playersshould include the key players
14
• How to apply:─ Go tG to www.medidicallcounttermeasures.gov
• Click on Procurement and Grant Opportunities• Scroll down and click on CBRN Funding Activities• Click on link for 2011 Broad Agency Announcement
─ OrOr gogo toto https://wwwhttps://www.fbofbo.gov/gov/• Search BARDA-CBRN-BAA-11-100-SOL-00009
─ Technical POC for Research Area #1: VaccinesEric M. Espeland, Ph.D., MBAEric espeland@hhs gov 202 205 [email protected] 202-205-7057
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